Dermatomyositis and Polymyositis Registry (ADAPT)

This study is currently recruiting participants.
Verified April 2013 by Phoenix Neurological Associates, LTD
Sponsor:
Information provided by (Responsible Party):
Phoenix Neurological Associates, LTD
ClinicalTrials.gov Identifier:
NCT01637064
First received: July 6, 2012
Last updated: April 2, 2013
Last verified: April 2013

July 6, 2012
April 2, 2013
April 2013
October 2015   (final data collection date for primary outcome measure)
Determining if Acthar treatment improves disease progression [ Time Frame: 2 years ] [ Designated as safety issue: No ]
To create and maintain a registry linking clinical information, dosing and clinical response in patients with refractory myositis and to determine if Acthar treatment improves disease progression
Not Provided
Complete list of historical versions of study NCT01637064 on ClinicalTrials.gov Archive Site
Subgroups may predict response to Acthar therapy [ Time Frame: 2 years ] [ Designated as safety issue: No ]
To determine if there are different subgroups that can be defined myopathologically that may predict response to Acthar therapy.
Not Provided
Not Provided
Not Provided
 
Dermatomyositis and Polymyositis Registry
Acthar Dermatomyositis and Polymyositis Treatment

By creating a registry, physicians will have the opportunity to understand the clinical outcomes of Myositis patients treated with Acthar. Despite the availability of clinical exams, muscle biopsies, and other testing, it is surmised that there may be a more important classification of myositis that physicians are not diagnosing which could possibly lead to improper treatment due to inaccurate diagnosis. There may be several types of immune and inflammatory myositis (IIM) that do not fit well into the typical sub classifications of myositis.

Retrospective and prospective data will be collected from physicians who have prescribed Acthar to myositis patients to determine what specific characteristics each patient has based on biopsy analysis, laboratory results, and clinical exams. Through biopsy analysis, subcategories of IIM will be determined and could illustrate which of these IIMs may be more responsive to Acthar therapy.

Observational
Observational Model: Case-Only
Not Provided
Retention:   None Retained
Description:

This is a retrospective and prospective study

Non-Probability Sample

All sites chosen are well-established universities, academic centers or private practices that specialize in neuromuscular diseases. These are physicians who have several myositis patients and who are prescribing or would prescribe Acthar to myositis patients

  • Dermatomyositis
  • Polymyositis
Drug: Acthar
Physicians will prescribe Acthar at their own discretion; however the recommended dose is 80 units subcutaneously twice a week.
Other Name: ACTH
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
100
Not Provided
October 2015   (final data collection date for primary outcome measure)

Inclusion Criteria:

  1. Age 18-85
  2. Male or Female
  3. Clinical or pathologic diagnosis of polymyositis or dermatomyositis
  4. Capable of providing informed consent and complying with treatment regimen

Exclusion Criteria:

  1. History of scleroderma, osteoporosis, systemic fungal infections, ocular herpes simplex
  2. Recent surgery, history of or the presence of a peptic ulcer, congestive heart failure, uncontrolled hypertension, or sensitivity to proteins of porcine origin
  3. Any other co-morbid condition which would make completion of the trial unlikely
  4. If female, pregnant or breast-feeding; or, if of childbearing age, an unwillingness to use appropriate birth control
Both
18 Years to 85 Years
No
Contact: Todd D Levine, MD 602 258 2432 levine865@aol.com
Contact: Nicole C Hank, MHSM 602 258 2432 nhank@pnal.net
United States
 
NCT01637064
ADAPT
Yes
Phoenix Neurological Associates, LTD
Phoenix Neurological Associates, LTD
Not Provided
Principal Investigator: Todd D Levine, MD Phoenix Neurological Associates, LTD
Principal Investigator: John Katz, MD University of California Pacific
Principal Investigator: Lisa Christopher-Stine, MD John Hopkins Hospital
Principal Investigator: Chet Oddis, MD University of Pittsburgh
Principal Investigator: Lara Katzin, MD University of South Florida
Phoenix Neurological Associates, LTD
April 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP